JP2009506835A - Method and apparatus for monitoring and controlling heat-induced tissue treatment - Google Patents

Abstract

In a method and apparatus for thermal treatment of tissue that irradiates skin with electromagnetic energy, the electromagnetic energy source includes a radio frequency (RF) generator, a laser, and a flash lamp. The device includes either a position sensor or a dose evaluation sensor, or both types of sensors. These sensors provide feedback to the controller. The controller can control electromagnetic source parameters, electromagnetic source activation, and / or sensor measurement parameters. An additional scanning delivery unit is operably connected to the controller or sensor to control the distribution of electromagnetic energy to the target site on the skin. Use of position measurement sensors and dose evaluation sensors allows the controller to automatically determine appropriate electromagnetic source parameters including, for example, pulse timing and pulse frequency.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is filed by Leonard C. et al. De Benedictis, George Frangines, Kin F. et al. Chan, B.M. Wayne Stuart III, Robert Kehl Sink, Thomas R. US Patent Law No. 119 based on United States provisional patent application No. 119 based on US Provisional Patent Application No. 60 / 712,358 entitled “Method and Apparatus for Monitoring and Controlling Thermally Induced Tissue Treatment” by Basil Huntash . The entire contents of the aforementioned US provisional patent application are incorporated herein by reference in their entirety.

  The present invention relates to a skin tissue treatment method and apparatus, and more particularly to a technique related to control of a dose (or radiation dose) from an electromagnetic source based on measurement of handpiece movement and / or skin tissue reaction.

  Many electromagnetic skin treatment systems require a great deal of training before physicians and nurses improve their skills to deliver energy evenly to a treatment site such as the face, neck, chest, or back. In most cases, doctors and nurses do not treat equally, resulting in uneven treatment, excessive treatment, or insufficient treatment. There is a need to develop more even photothermal and / or radio frequency (RF) treatments, especially for large areas.

  Moreover, not all patients respond the same way to the same level of treatment. Thus, even if exactly the same laser energy dose is delivered to two different patients, each patient's response may be substantially different. Within a single patient, skin reactions can vary from site to site. For example, forehead treatment may show a different response than neck treatment. If equal treatment parameters are used for all patients or all sites, the treatment parameters are typically tailored to the most sensitive patient or most sensitive site to prevent undesirable side effects. Designed. Designs tailored to the most sensitive sites or patients will often result in undertreatment for other sites or patients.

  Many medical laser systems for the treatment of the epidermis of the skin condition the function by pressing the foot pedal to cause delivery of a single pulse of therapeutic energy. This type of therapy device is slow and has a large number of repetitive movements that can be laborious for the operator. Other laser treatment systems fire the same pulse at a constant pulse repetition rate as the user moves the handpiece across the tissue. The system requires skill and increases the risk of over or under treatment under the control of an unskilled operator. Therefore, there is also a need for an approach to electromagnetic therapy that controls dose (or radiation dose) and adjusts dose levels in real time to prevent excessive and / or insufficient treatment.

  While Weckwerth Patent No. 6,758,845 describes the use of optical measurements of regularly spaced indiaia placed at or adjacent to a treatment site. The concept is limited by the application of regularly spaced marks that are counted to measure the distance the handpiece has been moved. This requires an accurate positioning of the mark to avoid errors. In addition, visible marks are difficult to remove after treatment and can leave an unsightly pattern on the skin after treatment.

  The Weckwerth '845 patent and the Talpalriu patent 6,171,302 describe mechanical roller systems that track handpiece movement. Mechanical roller systems, for example when used with gels, may not be reliable because there is no friction between the mechanical roller and the skin surface. This causes omissions and errors in the measurement of position parameters. Furthermore, the mechanical roller may rust or become rubbery, and as a result, it will not easily rotate, and is more likely to cause slipping and errors. Wear of mechanical parts causes similar errors.

  The Weckwerth '845 patent does not measure the target area directly, but rather about other systems that indirectly measure the position of the handpiece by interaction with a reference plane or reference point outside the target area. It is described. With this approach, the location of the treatment surface relative to the reference surface must be measured or controlled. In addition, these systems measure only one coordinate relative to the handpiece, which may indicate that the movement of the handpiece through the target tissue due to changes in handpiece posture is not captured by the sensor system. It means you can't. This causes an error.

  For large area treatments, an automated laser control system is required to adjust laser treatment parameters in real time depending on handpiece position, velocity, and / or acceleration, or on the laser treatment itself It is said. Thus, a feedback loop that increases the effectiveness of treatment by responding in a controllable manner to treatment variables such as treatment speed, handpiece angle, handpiece acceleration, patient-to-patient variation, variation between parts of the same patient What is needed is an apparatus and method for Preferably, a device that allows for faster and more reproducible treatments and requires less operator training and skill and / or responds in a controllable manner to treatment variables There is also a need for methods.

  The apparatus and method further preferably increases efficacy without increasing side effects or invasiveness, treats with relatively little pain and side effects, provides accurate delivery of a given therapeutic dose, or handpiece position parameter Rather than relying primarily on the measurement of, directly or in combination with other inputs in the feedback loop to directly measure the effectiveness and / or course of treatment, biological predictability, efficacy, and Allows monitoring of biological responses and treatment variables to increase safety and / or better control of dosage for eg photodynamic therapy (PDT) treatment, laser hair removal, or fractional laser resurfacing To.

  In general, the present invention provides feedback from one or more sensors used to measure handpiece positional parameters and / or skin response to heat or removal therapy applied by delivery of electromagnetic energy to the skin. Devices and methods for the treatment used are provided. The electromagnetic energy may be radio frequency (RF) or light. The position sensor and the dose evaluation sensor may be used separately or may be suitably combined so that the treatment can be varied depending on the combination of skin response and handpiece position parameters.

  In one embodiment of the present invention, a relative handpiece position measurement and an absolute handpiece position measurement are measured to determine a change in position of the handpiece associated with the treatment site.

  In one embodiment of the invention, skin contraction is measured using a dose evaluation sensor. In another embodiment of the invention, the one or more measured responses of the skin are such as skin birefringence, skin moisture content, skin elasticity, skin mechanical attenuation parameters, skin color, vascular and pigmented lesions. Including one or more of the following: skin characteristics, skin thickness, skin texture, wrinkles. These skin changes and other skin changes are like capacitive sensors, (hyper) spectral imaging, terahertz imaging, optical coherence tomography, confocal microscopy, ultrasonic imaging, coherent detection, thermal detection, thermal imaging system etc. May be measured using one or more technologies. Other skin reactions and measured amounts can also be used.

  In one embodiment of the present invention, the output of an erbium-doped fiber laser is a pending US application No. 60 / 652,891, incorporated herein by reference to create a series of graphics at the treatment site. And collimated and detected by a scanning delivery unit such as a galvanometer scanner or a star scanner as described in US application Ser. No. 11 / 158,907.

  In another aspect of the present invention, the scanning rate of the scanning delivery unit is controlled by the controller to deliver a predetermined pattern or dose, even when the handpiece speed varies within a selected range. .

  In one embodiment of the invention, a contrast enhancing agent is used to enhance the signal to noise ratio of the position sensor. For example, FD & C Blue No. 1 is preferably applied to the surface of the skin to improve the position sensor signal including an optical mouse chip, CCD array, or other detector array with at least 25 elements. obtain. It is preferred to use at least 25 elements as a 5x5 array because it provides sufficient image resolution to observe changes in positional parameters and / or dose response. If fewer detector elements are used, more sophisticated algorithms and / or more advanced electronics are typically used to identify handpiece positional parameters and / or skin reaction changes. Will be needed. Other contrast enhancing agents are fluorescent or provide maximum contrast enhancement using IR or UV irradiation. A wavelength selective coating on the optical elements of the system may be used in conjunction with a fluorescent contrast enhancing agent to remove one or more illumination wavelengths. For example, the wavelength selective coating can be designed to remove light that is used to enhance the response of the optical position sensor to improve the signal to noise ratio of fluorescent emission signals at different wavelengths.

  The contrast enhancing agent may be applied as a uniform or non-uniform pattern of similar or dissimilar shapes. This pattern of contrast enhancing agent may be applied using, for example, a roller, stamp, spray, and / or stencil. Contrast enhancing agents may be applied on or in adhesive materials such as those used for temporary tattoos.

  In selected embodiments of the invention, the position sensor may be used to measure mechanical mouse wheel or roller ball, non-coaxial coil, accelerometer, gyroscope and distance (s). One or more of a transmitter and receiver (s), a Doppler radar system, an ultrasonic time-of-flight measure, and the like.

  In another embodiment of the present invention, a preceding dose evaluation sensor and a subsequent dose evaluation sensor are used to measure different skin reactions resulting from thermal treatment.

  In another embodiment of the present invention, the scanning motion of the scanning delivery unit is not altered, but the pulse rate or pulse timing of the electromagnetic source is measured by at least one position sensor and / or at least one dose evaluation sensor. Depending on the controller. The pulse timing and scanner pattern is such that the beam is intentionally routed throughout the treatment site to reduce the treatment intensity and / or increase the size of each treatment zone created by each energy pulse. It may be selected.

  In another embodiment of the invention, normal skin is left at the site between individual treatment zones for administering fractional treatment. The remaining tissue serves to promote rapid healing of the damaged area, prevent scarring, and allow for higher treatment levels than can otherwise be achieved without side effects. Measurement of the position parameter can be used to accurately separate the treatment zones from each other so that the treatment dose can be appropriately controlled.

  In another embodiment, the density of fractional therapy is controlled through the use of feedback from position sensors and / or dose sensors.

  Other aspects of the invention include methods, apparatus and systems and methods, apparatus and system applications corresponding to the approaches described above.

  The present invention has other advantages and features that will be readily apparent from the following detailed description of the invention and the appended claims, when taken in conjunction with the accompanying drawings.

  The present invention discloses an electromagnetic system with automatic adaptive control of treatment parameters and / or activation (photothermal and / or RF). A nominal pattern and treatment rate can also be defined when the system initiates treatment, which is modified based on an algorithm that describes skin response to treatment and / or handpiece position parameters. Can be done. Whether the measurement of the positional parameter or the measurement of the skin reaction is performed depends on the specific measurement result. For example, if the handpiece moves very rapidly across the skin and the treatment power is proportional to the relative handpiece speed, bulk heating of the tissue may be of interest. In this case, the dose evaluation sensor is instructed by the controller to measure skin parameters associated with blisters resulting from excessive treatment. If the motion is slow, bulk heating and blistering are less of a concern and more of the processing power of the controller can be used instead to make a more accurate measurement of velocity using a position parameter sensor . Detailed embodiments of the invention are described as examples described below.

  In some embodiments, microdosimetry measurements and macrodosimetry measurements can be distinguished. Microdosimetry measurements are substantially limited to one or more zones that are being treated by a pulse or set of simultaneous pulses. For example, measurement of a 1.2 mm diameter area that is centered in common with the 1 mm diameter area that is to be treated is substantially at the site that is to be treated with a future pulse or a set of future pulses that occur essentially simultaneously. Because it is limited, it is micro dosimetry. On the other hand, macrodosimetry measurements are used to produce an average measurement of the area that includes both the area that is about to be treated (or was just treated) and the area that is adjacent. Used to evaluate a relatively large area. In some embodiments, the dose evaluation sensor is used to generate a microdosimetry measurement or a macrodosimetry measurement according to the feedback loop of the present invention.

  FIG. 1 is an illustration of an embodiment of the present invention showing a manually movable handpiece 100 configured to deliver electromagnetic treatment energy to skin 150 at a treatment site. The electromagnetic source 110 generates electromagnetic energy 130 that treats the skin. The controller 115 activates or adjusts one or more parameters of the electromagnetic source for the purpose of affecting therapy. Handpiece 100 includes a controller 115 comprising a computer, a radio frequency generator, and / or laser driver electronics. In other configurations, the controller 115 is external to the handpiece 100 and is operably connected to the handpiece 100 to control treatment parameters. The system further includes an additional scanning delivery unit 120 that is operatively connected to a scanner controller 125 that scans the electromagnetic energy 130 over the treatment site of the skin 150. An additional contact plate 139 that is mechanically coupled to the handpiece 100 is used to make good electrical or optical contact with the skin 150 to improve the control of delivery of electromagnetic energy 130. Sometimes. Position sensor 180 measures handpiece position parameters, and dose evaluation sensor 160 measures skin response to treatment.

  While the operator manually moves the handpiece 100 in the direction 101, or after the operator manually moves the handpiece 100, the position sensor 180 measures one or more positional parameters of the handpiece 100 and determines the dosage. Evaluation sensor 160 measures the skin response to the treatment parameter. The position sensor 180 and the dose evaluation sensor 160 communicate with the controller 115 and / or the scanner control unit 125. The controller 115 and / or the scanner controller 125 significantly changes the treatment in real time in response to the position parameter measurement and / or in response to the dose evaluation measurement.

  In some embodiments, the feedback loop comprising the controller 115 and / or scanner controller 125 in combination with the position sensor 180 and / or the dose evaluation sensor 160 may include treatment location, treatment zone overlap, treatment energy, treatment depth, treatment. It can be used to provide automatic control of treatment parameters such as power, treatment zone pattern, treatment cooling (including pre-cooling and post-cooling), and the like. These treatment parameters adjust device parameters that affect treatment such as optical focus or spot size, pulse width, pulse energy, pulse timing, pulse frequency, laser power, laser wavelength, spray cooling volume, spray cooling timing, etc. Can be controlled.

  The controller 115 is optionally operatively connected to the scanner controller 125, which may help to reduce the number of wiring connections from the sensor. Controller 115 may serve the functions of both controller 115 and scanner controller 125 as shown in the embodiment of FIG. 2A. For example, the functions of both the controller 115 and the scanner controller 125 can be performed by a computer or CPU operably connected to a memory that stores a computer program. Position sensor 180 and dose evaluation sensor 160 may be operably coupled to a single piece or may be integrated into a single piece. For example, a CCD chip can be used to measure changes in both movement and skin response.

  Detailed embodiments of the plurality of components in FIG. 1 are described in the examples described below. In one embodiment, the electromagnetic source 110 provides RF energy and the scanning delivery unit 120 is connected to a plurality of electrical contact pads in a contact plate 139 made of a non-conductive material such as molded plastic. An electrical switching network including an electrically controlled relay. Scan delivery system 120 can sequentially deliver a pattern of energy across the treatment site, or multiple relays can be activated to activate multiple treatment zones simultaneously.

  In general, the electromagnetic source 110 is a radio frequency (RF) source, a light source, or a combination of a radio frequency source and a light source. The RF source generates electromagnetic energy at a frequency in the range of 0.1-20 MHz, preferably in the range of 0.5-8 MHz. The light source generates light defined as electromagnetic energy having a wavelength in the range of 300 to 12000 nm for this application. It is preferred that the light energy exceeds the radio frequency energy as it allows the energy to be directed more accurately and more easily to the desired location on the skin. RF energy is particularly desirable for applications where a deeper penetration or targeting of the skin's unique implant is desired. The selection of RF energy or light energy is also made to reduce interference with the selected type of dose evaluation sensor and / or position sensor.

In the preferred embodiment, the electromagnetic source 110 is a laser and the electromagnetic energy 130 is a laser beam. Examples of lasers include Nd: YAG laser, diode laser, erbium fiber laser, CO ₂ laser, Er: YAG laser, Er: glass laser, flash lamp pump laser, free electron laser, thulium fiber laser, Raman shift fiber laser, Die lasers, gas lasers, argon lasers, and ytterbium fiber lasers are included.

  Skin reactions utilize one or more technologies such as capacitive sensors, (hyper) spectral imaging, terahertz imaging, optical coherence tomography, confocal microscopy, ultrasound imaging, coherent detection, thermal detectors, thermal imaging, etc. It can be measured by one or more dose evaluation sensors 160. In addition, one or more dose evaluation sensors 160 may include skin birefringence, skin moisture content, skin elasticity, skin mechanical attenuation parameters, skin features such as skin color, blood vessels and pigmented lesions, skin thickness, skin May measure texture, wrinkles, etc. Other types of measurement technology and other skin and tissue properties that can be measured will be apparent to those skilled in the art.

  A mechanical mouse or roller wheel with an encoder can also be used as the position sensor 180. However, it is preferred to use a non-mechanical position sensor that is largely independent of moving parts to measure position parameters. Non-mechanical position sensors are advantageous in that they increase measurement reliability on slippery surfaces and reduce the possibility of mechanical failure compared to mechanical position sensors.

  In one embodiment of non-mechanical position sensor 180, a coil sensor is used as described by Ben-Haim et al. In US Pat. No. 6,788,967, incorporated herein by reference. These sensor coils that are mechanically coupled to the handpiece 100 in an appropriate position are, for example, the maximum of the handpiece when the sensor coil is placed in a magnetic field generated by at least two radiators. It can be used to measure position information in three dimensions and / or up to three angular directions. Other geometric relationships and numbers of radiators and sensor coils can be used for measuring the 1 to 6 dimensional position parameters of the handpiece. Other non-mechanical position sensors, such as optical position sensors, are described below and may be removable from the handpiece.

  An example of the use of a coil sensor is shown in more detail in FIG. In FIG. 12, the magnetic position sensor 1280 is outside the handpiece 1200 and the magnetic source 1281 is attached to the handpiece 1200. The magnetic source 1281 can include three magnetic field source elements 1285A-C. The magnetic field source element is arranged so that the axis of the magnetic field source element extends in a three-dimensional space. The axes are directed, for example, in three mutually orthogonal directions. The magnetic position sensor can include three magnetic sensor elements 1284A-C that are located at a reference point and can be arranged to span a three-dimensional space.

  In a preferred embodiment, each of the magnetic field source elements 1285A-C and each of the magnetic field sensor elements 1284A-C comprises a loop antenna that is tuned to a desired frequency, eg, a frequency of about 10 kHz. Each of the loop antennas 1285A-C of the magnetic field source element 1282 may be driven by a current source, eg, an operational amplifier current source. Alternatively, a single current source 1288 may be electronically switched to sequentially power each loop antenna of the magnetic field source elements 1285A-C. Preferably, the system is operated with a short-range magnetic field of each magnetic field source element 1285A-C and each magnetic field sensor element 1284A-C, although operation at a long distance is also possible. The magnetic field source elements 1285A-C may be powered sequentially to time multiplex the source signals. The controller 1215 comprises receiver electronics that measure the response detected by the magnetic field sensor. The receiver electronics portion of the controller may be placed with the magnetic field sensor elements 1284A-C or may be integrated with other electronics of the controller 1215. The controller comprises suitable electronics that demultiplex the received signal to identify the measured magnetic field strength due to each one of the magnetic field source elements. In order to synchronize the system, in particular in the case of time division multiplexing, a common clock can be used for the source electronics and the receiver electronics. The source, receiver, multiplexing / demultiplexing, and other configurations of the electronics system will be apparent. For example, further embodiments and improvements of suitable magnetic field systems are described in US Pat. Nos. 4,613,866, 4,737,794, 4,742,356, which are incorporated herein by reference. And No. 5,307,072.

  In an alternative embodiment, the magnetic field source elements 1285A-C are located at one or more reference points outside the handpiece, and the magnetic field sensor elements 1284A-C are attached to the handpiece. The location and orientation of the treatment beam (s) emitted from the handpiece is measured at the time of emission with respect to the reference coordinate system. For treatment on the face, the handpiece 1200 can include a magnetic source 1281 and a mini earbud placed inside the patient's ear can include a magnetic position sensor 1280. A second magnetic position sensor (not shown) may be used, for example, on the opposite ear of the patient to increase accuracy and determine that the earbud has come off or moved. If there is a discrepancy between redundant sensors, the system alerts the physician using, for example, an audible alarm.

  The choice of which of the magnetic source 1281 and the magnetic position sensor 1280 is located at the reference point (s) and placed on the handpiece 1200 depends on the source of electromagnetic interference and the metal plate, etc. It can be chosen based on the subject of electromagnetic field distortion. In the case of the above example, it can be seen that for example, there is a scanning motor element that is used to rotate the scanner wheel 220 about the axis 221 in FIG. The impact of the scanning motor element on the measurement system is reduced by placing the source on the handpiece instead of the sensor. In an alternative arrangement, for example, the handpiece is free of electromagnetic elements, in which case the sensor is properly placed on the handpiece and the source is located at a reference point. Moreover, the system can be empirically calibrated to at least partially compensate for fixed elements that distort the magnetic field.

  In one embodiment of a magnetic field system as described in FIG. 12, a Polhemus Patriot digital tracker system (available from Polhemus, Colchester, Vermont) measures the position of the handpiece relative to a reference point. Used for. An example of measurements made using this system is shown in FIG. 13, which represents a 2D projection 1301 of a 3D data set for half of the face.

  In one embodiment of the present invention, the one or more measured handpiece position parameters include the handpiece position, or handpiece angle (angular direction), or handpiece speed, handpiece acceleration, handpiece angular speed, and , Including time variations of these two parameters, including handpiece angular acceleration. The handpiece position parameter may be absolute or relative to the treatment site.

  To increase the usefulness of the device and allow the handpiece to be replaced and share expensive components, the handpiece is removed from one or more of the electromagnetic source 110, the controller 115, and the scanner controller 125. Is possible. In order to reduce the weight of the handpiece, these components may be located outside the handpiece. Alternatively, these components can be included inside the handpiece to increase the portability of the device.

  The scanning delivery unit is configured to receive and deliver electromagnetic energy 130 to the skin 150 regardless of where other components are housed. For example, the electron source 110 may be a laser. Electromagnetic radiation is coupled into an optical fiber, optical waveguide, or articulated arm for delivery to the handpiece. The handpiece can accept light energy by using a fiber coupling or a fiber collimator. Similarly, it will be apparent to those skilled in the art that sensors 160 and 180 should be operatively coupled to controller 115 and may not be located inside the handpiece.

  Controller 115 and scanner controller 125 may be separate components as in FIG. 1 or may be combined as a single controller as shown in FIG. 2A.

  In the embodiment of FIG. 2A, the laser source 210 is used as an electromagnetic source. In this embodiment, the manually movable handpiece 200 is configured to deliver a light beam 230 of electromagnetic energy to a treatment site on the skin 250. The handpiece 200 houses a controller 215 that includes a computer and / or laser driver electronics. Controller 215 controls light source 210 and scanning delivery unit 220 to affect one or more parameters such that treatment is substantially affected. The light source 210 generates a light beam 230 that is directed to an additional scanning delivery unit 220. Scan delivery unit 220 deflects laser beam 230 to various treatment zones on or within skin 250 as described in detail below. For clarity, only one beam position is shown in FIG. 2A. In a particular embodiment, it is advantageous if a dichroic mirror 232 and a contact plate 239 that are substantially transparent at the wavelength of the laser beam 230 are included. The deflected laser beam 230 is delivered to the skin 250 via the dichroic mirror 232 and the contact plate 239. The beam delivery lens 231 can be used to focus the deflected beam 230 into the epidermis 251, dermis 252, or other layers of the skin 250. The focal point of the light beam 230 may be below the skin surface, or the beam may diverge or collimate as it enters the skin 250. A dose evaluation sensor 260 is mechanically coupled to the handpiece 200 and measures the skin response to treatment.

  In the embodiment of FIG. 2, position sensor 280 measures the relative position of the handpiece with respect to the surface of skin 250. In an alternative embodiment, position sensor 280 measures the relative position, velocity, and / or acceleration of the handpiece relative to the surface of skin 250. The illumination source 282 emits illumination light 283 that is collimated by the illumination delivery lens 284 for delivery to the surface of the skin 250. The collimation of the illumination light 283 increases alignment tolerances, improves the illumination uniformity on the skin surface, and the illumination source 282 generates a uniform profile of the illumination light 283 from the treatment site to possibly the skin 250 surface. It is possible to be arranged further apart than in other cases. The illumination light 283 is scattered from the surface of the skin 250 or from a contrast enhancing agent 290 that is placed in or on the skin 250. The spectral reflectances of the dichroic mirror 232 and the reflecting prism 287 are designed to substantially affect the wavelength of the scattered illumination 285. The detector lens 286 is placed in the optical path from the skin to the position sensor 280 to image the surface of the skin 250 on the optical position sensor 280. Examples of the optical position sensor 280 include an optical mouse chip (Agilent Technologies, Palalto, Calif.), A CCD camera, or an optical sensor array having at least two sensor elements. Preferably, the photosensor array has at least 25 sensor elements arranged in a 5x5 array to possess sufficient resolution that facilitates accurate quantification of the range of velocity resolution. Preferably, this optical position sensor is silicon based so that it can be manufactured at low cost using mass production processes and inexpensive material resources developed for the electronics industry. Other configurations will be apparent to those skilled in the art.

  In FIG. 2A, the direction of handpiece movement 201 (not shown) is essentially perpendicular to the page. FIG. 2B is a side view of the handpiece showing the direction of movement 201 of the handpiece 200. For simplicity, the internal elements of handpiece 200 are not shown in FIG. 2B. While the handpiece 200 is moved manually by the operator in the direction 201, the position sensor 280 measures one or more positional parameters of the handpiece, and the dose evaluation sensor 260 measures one or more skin responses to the treatment. taking measurement. Position sensor 280 and dose evaluation sensor 260 communicate with controller 215. Depending on the measurement, the controller 215 adjusts the optical therapy parameters in real time to substantially affect the photothermal therapy. For example, the rate of laser firing can be adjusted to be proportional to the speed of the handpiece 200 to provide a predetermined treatment pattern or uniform treatment.

  An example of a dose evaluation sensor 260 is a capacitive sensor as shown in FIGS. 2A, 2B and 2C. The capacitive sensor 260 can measure the level of dryness of selected layers of skin due to treatment. The measured amount from the capacitive sensor 260 is used to calculate an appropriate dose parameter for treatment using the controller 215 and to adjust the treatment parameter. Capacitance sensor 260 is also used to evaluate whether the skin site is swollen. By imaging the junction between the dermis and the epidermis, the capacitive sensor can determine whether separation of the dermis and the epidermis has occurred. In other embodiments, a sensor that measures or images skin resistivity is used as a dose evaluation sensor 260 to evaluate blisters and skin moisture content. A capacitive sensor array generally used for fingerprint measurement is an example of a sensor used as the capacitive sensor 260.

  FIG. 2C represents a treatment pattern that includes separate micro-treatment zones 256 that can be created using this technique when the handpiece 200 is moved across the treatment site 257 in a direction 201. In this embodiment, co-pending US applications 10 / 367,582, 10 / 751,041, 10 / 888,356 and 60/60, which are incorporated herein by reference. Separate microtherapy zones 256A, 256B and 256C are created in the skin, as described in 652,891. Preferably, the treatment zone 256 is created in a predetermined pattern that does not change with respect to the relative velocity or acceleration of the handpiece 100. Other patterns will be apparent to those skilled in the art. A substantially uniform treatment range is created by appropriate selection of optics, treatment parameters, and laser pulse timing. Further, the capacitive sensor 260 provides feedback to the controller 215 so that the treatment parameters are adjusted to reduce the density of the fine treatment zone 256 or to reduce the treatment power in response to excessive treatment.

  In an alternative embodiment, the pattern may be changed in real time in response to changes in handpiece speed or acceleration, and the treatment rate intentionally changed according to a predetermined algorithm with no predetermined treatment pattern. For example, the treatment pattern is controlled in real time by the user by appropriately adjusting the position, velocity or acceleration of the handpiece. For some therapies, it is desirable for the operator to be able to control the level of therapy by using speed. For example, if the user treats quickly, the system is configured to allow a higher level of therapeutic response as measured by the dose evaluation sensor 260. If the user treats slowly, the maximum acceptable therapeutic response may be reduced. Therefore, the user can easily control the treatment setting condition by changing the position parameter of the handpiece. Thus, the treatment pattern, treatment density, treatment intensity, and other treatment parameters may not be predetermined, but are measured with measured location parameters, measured treatment responses, or measured location parameters. It may be determined by an automatic response to both treatment responses. An electronic or computer interface (not shown) may be provided to allow the various modes of user-controlled equipment to be turned on or off.

  In another embodiment, a treatment status map is displayed on a monitor (not shown) for viewing by a user or patient. The position sensor 280 is used to measure the location of the tissue reaction measured by the dose evaluation sensor 260 within the treatment site. In this way, the map can display the treated part of the treatment site and how each part of the treatment site responds to the treatment. The user can use the information on this map to change the treatment in a desirable way to treat it uniformly across the treatment site, or to treat deeper areas more deeply than areas with less wrinkles. Can be used. Alternatively, the system is configured to automatically reduce or inhibit treatment at a site that has already been properly treated as the user continues to move the handpiece over the treatment site. . An image or schematic representation of a treatment site, such as a line drawing of a face for treatment of wrinkles on the face, is used as a background for computer display of a map of treatment response measures.

  The use of position sensor 280 and / or dose sensor 260 to create a map is particularly useful with small beam sizes that are less than 1 mm in the smallest dimension. Using such a map, treatments can be switched on and off based on whether the treatments cover the area. The advantage of using a beam size of less than 1 mm is that the granularity of the treatment beam size visible after treatment is less noticeable for such small beam sizes. Thus, the use of position sensor 280 or density sensor 260 is particularly suitable for fractional therapy and / or therapy with a small beam size of less than 1 mm.

  The controller 215, light source 210, and other components may be external to the handpiece 200, rather than included inside the handpiece as shown in FIG. 2A. The light beam 230 can propagate to the handpiece through free space, through an articulated arm, or through a waveguide, such as an optical fiber. The handpiece 200 may be mechanically separable from external components or may be mechanically separated, or the handpiece 200 may receive signals from the light beam 230 and / or the controller 215. May be configured to receive.

  In a preferred embodiment, the electromagnetic source 210 is a single mode pulsed erbium doped fiber laser with a peak output power in the range of 5-50 W and a wavelength in the range of 1.52-1.62 μm. This laser source is focused on the surface of the skin to a light spot size in the range of 30-600 μm, preferably 60-300 μm. Pulse energies that fall in the 2-100 mJ range, preferably in the 8-20 mJ range, are used for the light spot size, wavelength, and power in these ranges. This preferred embodiment does not include surface skin cooling, but such cooling is incorporated as needed to reduce damage to the epidermis and dermis-epidermal junction.

  Scan delivery unit 220 used in this embodiment is described in detail in US application 60 / 652,891 and corresponding US application 11 / 158,907, which are incorporated herein by reference. As shown, the scanner wheel rotates at least 360 ° about the axis 221. Other scanner types will be apparent to those skilled in the art. For example, galvanometer scanners, quasi-fixed deflection (PSD) scanners, polygon scanners, light valves as described in co-pending US application Ser. No. 10 / 750,790, which is also incorporated herein by reference. LCD screens, MEMS based reflective scanners, and translation stages are used in scanning delivery units for the delivery of light energy. Multiple scanning delivery units are used in such systems to control multiple deflection axes. For example, two galvanometer scanners are used in series to scan the laser beam in two directions so as to cover an area on the surface of the skin 250. Alternatively, a single scanning unit can cause beam deflection in two directions, as detailed in U.S. Application Nos. 60 / 652,891 and 11 / 158,907. .

  One algorithm used to control the operating parameters of the scan delivery unit 220 is to adjust the rotational speed of the dual or single wheel PSD scanner and the laser firing rate proportional to the handpiece speed. is there. This allows the fractional resurfacing microtherapy zone to be placed in a predetermined pattern on the skin.

  Another algorithm for controlling treatment is to adjust the laser firing approximately proportional to the relative velocity of the handpiece to create a predetermined density of treatment zones. A uniform distribution of treatment zones across the treatment site by overlapping or adjoining treatment zones is also realized. For example, if the scanner 220 shown in FIG. 2A is controlled to rotate at a constant angular velocity when the handpiece 200 is moving across the surface of the skin 250, laser firing may be achieved if the laser is desired. By firing the laser only when aligned with the scanner's special facets that create the treatment distribution or density, it is possible to pulse to create the desired treatment zone density within the treatment site. Not all facets need be used. All facets are used for special speeds. If the speed is reduced from this special speed by a factor of 3, only one out of every three facets is used to keep the same density. Preferably, the algorithm maintains a uniform distribution of treatment zones within the treatment site. Rotating the scan wheel 220 at a constant angular velocity reduces the complexity of the motor and encoder associated with the drive electronics used to accurately control the angular velocity of the scan wheel 220, so It is desirable to require that the angular velocity of the scan wheel 220 is proportional to the velocity of the handpiece 200.

  In another embodiment, the scanner wheel 220 is moved at a speed that pulls the light beam 230 across the treatment site. This wheel speed may be in the opposite direction that would compensate for the movement of the handpiece. This intentional pull of the light beam 230 across the surface of the skin 250 is created using either a variable speed scanner system or a fixed speed scanner system. Using a fixed speed system, for example, the pulse interval of the laser beam is adjusted according to the speed of the handpiece 200 so that the light beam is pulled across the skin by approximately the same distance as each pulse. By changing the angular velocity of the scanner wheel 220 or changing the pulse interval of the light beam 230, the distance over which optical treatment is performed for each pulse is changed. Controlled pulling of the light beam is used to increase the filling rate of the fractional resurfacing treatment, for example by making each fine treatment zone larger by increasing the distance over which the optical treatment is performed. As the speed of handpiece 200 is reduced, the increased pulse interval defined by this algorithm may cause a decrease in therapeutic response as measured by dose evaluation sensor 260. Therefore, it is desirable to increase the pulse energy to keep the tissue response the same.

  The contact plate 239 effectively optically scatters the treatment beam from the skin surface by creating a smooth surface that is used to accurately and reproducibly position the skin relative to the depth of focus of the light beam 230. To reduce. Contact plate 239 can serve as a thermal heat spread, or when connected to a cooling source (not shown), away from the surface to actively cool the skin. It is possible to conduct heat. Contact plate 239 and dichroic mirror 232 may include sapphire, fused silica, borosilicate glass, transparent plastic, or other transparent material. Contact plate 239, dichroic mirror 232, and other optical components may include one or more to improve the efficiency of energy delivery to the skin or to enhance the reflection or transmission of illumination light 283 from illumination source 282. An optical coating is applied to the side of the substrate.

  In certain embodiments, the contact plate 239 may not be desirable and may be omitted. For example, in ablative laser treatment, it may be desirable for the skin surface to be mechanically free to enhance the ablation response of the treatment.

  In order to enhance the ability of the optical position sensor 280 to read the position parameters of the handpiece 200, a contrast enhancing agent 290 is applied over or into the skin 250. For example, uniform application of pigment on the surface of skin 250 preferentially makeup certain features, such as skin wrinkles or hair follicles, to create a shape that is detected as an object by position sensor 280. It is possible. Contrast enhancer 290 must be non-toxic when applied in or on the patient's skin in an amount suitable to properly enhance the amount measured by position sensor 280. Preferably, the contrast enhancing agent and the selection of materials and geometric properties for the handpiece 200 and contact window 239 allows the handpiece 200 to easily slide on the surface of the skin 250.

  Examples of contrast enhancing agents 290 are carbon particles, ink, and FD & C Blue No. 1. A number of other dyes, inks, particles, etc. are used as contrast enhancing agents when applied to the skin and used with an appropriate position sensor 280. The wavelength illumination source 282 is selected to maximize the signal-to-noise ratio of the measured quantity of the position parameter of the handpiece 200. For example, red LEDs with peak wavelengths in the range of 600 to 640 nm are used with FD & C Blue No. 1.

  In many cases, contrast enhancing agents have less absorption of therapeutic wavelength in the case of therapeutic energy or optical therapeutic energy. Thus, the contrast enhancing agent does not interfere with the deposition of therapeutic energy at the treatment site. In some cases, the contrast enhancing agent is selected such that the measurable or observable parameter changes in response to treatment energy. The change in contrast enhancing agent can be used to determine whether treatment has been performed, allowing treatment to be modified in areas that are not uniform or uniform.

  It is desirable to choose a contrast enhancing agent 290 that is removed without harsh or unpleasant scrubbing. Alternatively, a removal facilitating substance (not shown) may be applied prior to application of the contrast enhancing agent 290 so that the dye can be more easily removed. Dimethicone, urea, and arginine are examples of removal promoting substances. These materials may be applied before the contrast enhancing agent 290 to facilitate subsequent removal of the contrast enhancing agent 290. These materials are applied using customary solvents such as water, alcohol or oil. The concentration of the removal promoting substance is used in the range of 0.001M to 0.1M, for example.

  It is desirable to select a contrast enhancing agent 290 that is not clearly visible when illuminated with typical room light and / or sunlight. When contrast enhancement agent 290 is applied so that the response of detector 280 is advantageously and substantially enhanced when using illumination wavelengths from 300-400 nm to 700-1100 nm, It is said to be “low visibility” if and only if the contrast enhancing agent is not readily visible on the naked skin with the naked eye when illuminated with 400-650 nm light. The use of low-viscosity contrast enhancer 290 is desirable because contrast enhancer 290 loses visibility after treatment, even if not all of contrast enhancer 290 has been removed from the treatment site. is there.

  Many fluorescent inks, pigments, and particulates are examples of low visibility contrast enhancers 290. The reason why fluorescent agents are desirable is that the wavelength of the illumination light can be filtered by dichroic mirror 232 or other optical components or coatings, while the throughput of fluorescent emission wavelength is to increase the signal to noise ratio of position sensor 290. This is because it is maximized. Polymer (PMMA) encapsulated fluorescent dyes are manufactured commercially by NewWest Technologies (Santa Rosa, Calif.). Other fluorescent materials include collagen, elastin, FD & DC orange No. 5, flavin adenine dinucleotide, folic acid, nicotinic acid, nicotinamide, reduced nicotinamide adenine secondary nucleotide (NADH), porphyrene, pyranine (FD & C green No. 7), pyri Dosine hydrochloride, quinine sulfate, riboflavin, riboflavin phosphate, tryptophan, uranin (fluorescein), or combinations thereof are included. The absorption and emission spectra of these materials are widely published in the art. Other fluorescent materials that are widely known in the art are also used as contrast enhancing agents 290, such as Carbazine, Coumarin, Stilbene 3, Kiton Red.

  The intensity of the fluorescence emission of pyramine changes with pH. Thus, pyramine assesses changes in barrier function and warns the user if the stratum corneum disruption or skin rupture occurs during treatment, or automatically stops treatment or treats Reduce strength. Accordingly, the contrast enhancing agent 290 is also used to improve the signal to noise ratio of the dose evaluation sensor 260.

  Indocyanine green (ICG) is an example of contrast enhancer 290. Most contrast enhancing agents 165 can be diluted with water or other solvents for ease of application or for cheaper use. The peak wavelength of ICG varies depending on the solvent and the concentration of ICG. For example, in water, ICG has an IR absorption peak at approximately 700 nm at high concentrations (eg, 129-1290 μM) and an IR absorption peak at approximately 780 nm at low concentrations (eg, 6.5-65 μM). Have For ICG in plasma, there is an absorption peak in the range of approximately 790-810 nm over a wide range of concentrations (6.5-1290 μM). In general, ICG typically has an absorption peak in the range of 650-850 nm for most solvents. ICG also has an absorption peak in the UV range. ICG does not retain a strong absorption peak in the 400 to 650 nm range, making it difficult to see with the naked eye. Thus, ICG is an example of a contrast enhancing agent that has low visibility to the human eye, but can be easily distinguished with a silicon-based photodetector when properly illuminated. For non-fluorescent contrast enhancing agents, the wavelength (or wavelength range) of the illumination light is at least 3 times, preferably at least 10 times stronger or weaker than the peak absorption of the contrast agent. It is possible to choose to fall within the range. Make the peak absorption of the contrast agent that falls in the selected wavelength (or wavelength range) at least 3 times, preferably at least 10 times stronger or weaker than the peak absorption in the wavelength range of 400-650 nm. Is more desirable.

  The contrast enhancing agent may be applied in a pattern. The pattern may include a uniform grid of identical figures 391 within the treatment site 357, as shown in FIG. 3A. The pattern may include a non-uniform pattern of the same graphic 392 within the treatment site 357, as shown in FIG. 3B. The pattern may include a non-uniform pattern of a plurality of various graphics 393 within the treatment site 357, as shown in FIG. 3C. The contrast enhancing agent can be applied using a stamp, roller, spray, stencil, or using a gauze pad impregnated with the enhancing agent.

  The contrast-enhancing agent pattern may be attached to the skin using an adhesive such as that used for temporary tattoos. Similar to temporary tattoos, the pattern is created by printing a contrast enhancing agent on the adhesive that adheres to the skin or by embedding the contrast enhancing agent in an adhesive that adheres to the skin. . Adhesives have the advantage of being easier to remove than many contrast enhancing agents contained in or on the adhesive. FDA approved color lakes such as FD & C Blue No. 1 (and packaged as OptiGuide Blue by Reliant Technologies, Palalto, Calif.) Are embedded in a polymer based tattoo adhesive and applied to the skin. Following treatment, these adhesive-based patterns are removed using alcohol and light scrubbing. Because the adhesive is designed to provide a barrier between the skin and the contrast enhancing agent, the use of the adhesive also allows the contrast enhancing agent to be used in irradiation that would have been toxic to the skin It becomes.

  Alternatively, the contrast enhancing agent may be suspended in a sugar-based solvent or gel-based solvent without patterning. These solvents are preferably viscous so that they do not sag outside the treatment area.

Instead of applying a graphic pattern with a contrast enhancing agent, the laser treatment zone may form a graphic pattern that is used to enhance the response of the position sensor 280. For example, CO ₂ laser, to create a pattern of the release area interspersed inside the non-peeling area can be peeled portion of the skin. This pattern is illuminated with LEDs to give a visual shape that enhances the signal-to-noise ratio of the optical mouse chip that functions as the position sensor 280.

  Another embodiment of the position sensor 280 is shown in FIGS. 4-7. Another embodiment of the dose evaluation sensor 260 is shown in FIGS. 8-11. By using one or more of these sensors, various measurements can be made to optimize the tissue treatment level. The treatment density and treatment level are either kept constant or maintained within a prescribed range by a controller 215 that appropriately adjusts the treatment parameters of the electromagnetic source 210 and the scanning delivery unit 220.

  The position sensor and dose evaluation sensor shown in FIGS. 4-11 may be added to the embodiment shown in FIGS. 1 and 2 or may be used instead. As will be apparent to those skilled in the art, many of these systems can be easily designed such that the site detected by the dose evaluation sensor coincides with the site measured by the position sensor and the site being treated. . In situations where it is not desirable to match two sensors or where these two types of sensors interfere, the dose evaluation sensor is moved in the x, y or z direction relative to the position sensor. Sometimes.

  The embodiment shown in FIG. 2 represents the delivery of light energy to the treatment site, but the contact plate 239 delivers RF energy to the desired treatment site under the control of a controller 215 comprising an RF generator. Instead of light energy, monopolar or bipolar radio frequency (RF) energy is used as well by replacing it with a contact plate, contact electrode, or needle electrode that is configured to do so.

  FIG. 4 shows an embodiment of the invention. In this embodiment, the position sensor is implemented as a set of one or more accelerometers 480 and 481 that are mechanically coupled to the handpiece 400. The set of accelerometers 480 and 481 may be attached to the inside of the handpiece 400 or to the outside. A set of three accelerometers 480A, 480B and 480C is used to measure the change in velocity in each of the three coordinate planes. One or more sets of accelerometers 480 and 481 can communicate with a controller 415 that controls the operating parameters of the electromagnetic source 410. The electromagnetic source 410 emits electromagnetic energy 430 and delivers it to the skin 450 via the contact plate 439. The configuration shown in FIG. 4 can also include a scanning delivery unit (not shown) as shown in FIGS.

  As shown in FIG. 4, a pair of accelerometers are used to measure angular acceleration in each of the three rotational directions. For example, accelerometers 480A and 481A measure angular acceleration around a rotation axis parallel to the z axis, accelerometers 480B and 481B measure acceleration around a rotation axis parallel to the x axis, and accelerometers 480C and 481C are y Measure the angular acceleration around the axis of rotation parallel to the axis. Accelerometers 480B and 481B are offset from each other in the z-axis direction and are depicted as overlapping in FIG. Alternatively, a gyroscope is used to measure the angular velocity of the handpiece. MEMS-based accelerometers and gyroscopes are sold by multiple suppliers (eg, Kionix, Inc., Ithaca, NY).

  Acceleration or angular acceleration measurements may be integrated in time to generate velocity and position, or angular velocity and angular position measurements. In many configurations, initial calibration and periodic recalibration may be required to reset the reference velocity, angular velocity, position, and / or angular position.

  The accelerometer measures the absolute position parameter of the handpiece 400 rather than the relative position parameter of the handpiece 400 with respect to the treatment site of the skin 450. If a relative position parameter is desired, the accelerometer can be used when the treatment site is fixed or when the absolute motion of the treatment site is small. Alternatively, both the absolute movement of the treatment site of skin 450 and the absolute movement of the hand piece 400 are measured and the relative movement between the hand piece 400 and the treatment site of the skin 450 is calculated.

  Relative measurement of angular position is used to provide feedback to the system and disable the laser unless the relative angle of the handpiece falls within a certain angular range relative to the surface perpendicular to the treatment site surface. Is done. This helps, for example, to properly align the cooling spray and treatment laser beam on the treatment site. The absolute measure of angular position is useful if the handpiece 400 has a gravity sensitive component such as a liquid filled cavity that leaks if it is rotated upside down. The relative measure of position is used to measure the distance between locations where the electromagnetic source 410 is pulsed.

  The absolute or relative measurement of velocity, acceleration, angular velocity and angular acceleration is based on the presence or absence of handpiece dropping that may lead to unwanted treatment outside the desired treatment area, or abrupt handpiece in an uncontrollable manner Useful for evaluating the presence or absence of slippage. The combination of relative position parameter measure and absolute position parameter measure is used to measure patient movement. For example, if the patient moves suddenly, the difference between the relative acceleration measurement and the absolute acceleration measurement can be significant. In any of the situations described in this paragraph, the controller 415 temporarily disables the electromagnetic source 410 to prevent treatment in areas not desired by the user.

  FIG. 5 shows another embodiment of the present invention. In this embodiment, the position sensor comprises at least two pairs of transmitters and receivers that implement either unidirectional or bidirectional wireless communication. Transmitters 580A-C are installed to transmit signals to one or more receivers 581A-B that are mechanically coupled to handpiece 500. The signal from the receiver is received by the controller 515, which uses the time-of-flight measure or phase measure to calculate the distance between each pair of transmitters and receivers. These distances are used to calculate selected position parameters of the handpiece that can be performed by the controller 515. The controller 515 may be operatively connected to other components of the handpiece, such as the electromagnetic source 110, the scanner controller 125, or the scanning delivery unit 120, as shown in FIG. These components may be placed inside or outside handpiece 500 and are not shown for simplicity.

  The number and location of transmitters and receivers determine the location parameters that can be measured. Three transmitters and one receiver are used to measure the position of the handpiece in three dimensions. A second receiver may be used to measure the position of the handpiece in up to three dimensions and to measure the angular position in up to three independent angular directions. In order to measure all three dimensions and all three handpiece angles, three transmitters and three receivers are preferably used to maintain redundancy. A simple device comprises two transmitters and one receiver. This device is used with a transmitter to measure handpiece position parameters in two dimensions along a given surface. In another configuration, two receivers are used with one transmitter to perform the same measurements as described above. The special geometric relationships and positions of these transmitters and receivers can be generalized by those skilled in the art.

  For simplicity in the examples described below, the receiver is placed on the handpiece and the transmitter is placed on the treatment site so that the measured positional parameters of the handpiece are relative to the treatment site and not an absolute measurement. Located inside 557 or mechanically coupled to treatment site 557. Other configurations are also used if absolute measurement is desired. Light-based communication systems or other electromagnetic communication systems are similarly used for these types of systems.

  In one embodiment, three radio frequency transmitters are preferably attached to a cap made of cloth or latex for ease of use and low cost. For example, the transmitter is attached to an EEG cap for this purpose. This type of cap is useful for positioning the handpiece, for example, when treating a forehead or eyelid area in the face orbit because the transmitter is mechanically coupled to the treatment site. This type of cap can also be used with the coil measurement system described in the description with reference to FIG. In some embodiments, a single chip receiver similar to the receiver commonly used in cell phones or GPS tracking systems is attached to the cap. Alternatively, the sensor or receiver is attached directly to the treatment area or other area of the body, such as the teeth, nose, jaw, using an adhesive. If the sensor is correctly placed at the same location for each treatment, for example, on the same tooth, an overlay map is created to illustrate the treated area continuously for each treatment.

  One advantage of accelerometer, magnetic, gyroscope, and transmitter / receiver based measurement systems is easy to use in non-contact mode, reducing the possibility of skin movement during treatment and entering the skin surface To allow the handpiece to be held at various distances from the skin to manually adjust the beam size.

  Multiple position sensors are also used, for example, to allow relatively low quality signals from each position sensor. For example, an optical mouse type sensor can be used with a magnetic radiator coil measurement system. The combination of multiple sensors is also used to shut down the system when a major contradiction is noticed between the sensors. If different types of sensors are used, the contradiction is used, for example, to provide additional information regarding whether the skin is stretched. This information is used to detect situations when the handpiece is not sliding properly and provides feedback to the system to reduce local overtreatment and inadequate treatment The

  FIG. 6 illustrates another embodiment of the present invention in which a manually movable handpiece 600 is configured to deliver light energy to the skin. An ultrasonic transmitter 680 is installed on one side of the contact plate 639, and an ultrasonic receiver 682 is installed on the opposite side of the contact window. A time-of-flight measure or phase measure is recorded to measure the distance of propagation between the transmitter 680 and the receiver 682. This is used to measure the speed of handpiece 600 along direction 601 relative to skin 650.

  FIG. 7 shows an embodiment of a position sensor and handpiece 700. The phased array of the ultrasonic transmitter 780 is installed on one side of the contact plate 739, and the ultrasonic receiver 782 is installed on the same side of the contact window. Phased array 780 emits a directional ultrasound beam that is scattered or reflected from one or more features 753 in or on the skin to ultrasound receiver 782. Using a phase shift, time of flight, or Doppler frequency shift metric, a controller (not shown) is used to measure a position parameter of the handpiece 700 as the handpiece 700 moves in direction 701. Is done.

  The ultrasound transmitter / receiver pair shown in FIGS. 6 and 7 can also be used as an embodiment of the dose evaluation sensor 160 of FIG. 1 by appropriate selection of frequency, preferably measuring due to velocity. Used in conjunction with a speed sensor to eliminate changes in value.

  FIG. 8 shows an embodiment of the dose evaluation sensor 160 of FIG. In this embodiment, a polarized illumination source 862 is used to illuminate the skin 850 via the illumination lens 864 and the light transmissive contact plate 839. A polarization imaging system comprising an imaging sensor 860, a polarizer 867, and an imaging lens 866 has been used to image the birefringence of the treatment site on the skin 850. The imaging sensor 860 is consequently operatively connected to the controller 115 shown in FIG.

  During certain photothermal treatments, skin collagen solidifies, causing loss of collagen photorefractive properties. This change in birefringence is measured by the imaging sensor 860 and used, for example, as the end point of a treatment pulse to control the interval between treatment pulses.

  Polarizer 867 may be adjustable (automatically or manually) to make alignment easier or more accurate, or to allow comparison of cross-polarized and parallel-polarized images.

The embodiment shown in FIG. 8 may be used to measure skin contraction, preferably by measuring the separation distance between two features on the skin before and after treatment. One or more imaging sensors 860 are used. Shrinkage can also be measured using a single measurement by measuring the separation distance between individual treatment zones starting from a known distance. For example, an ablative CO ₂ laser can place two marks at a set distance of 15 mm, after which the separation between these marks is measured to determine skin contraction. Polarizer 867 may not be required for these measurements, and illumination source 862 may be unpolarized.

  In another implementation of the dose evaluation sensor shown in FIG. 8, illumination light is used to increase the signal level of the light dose evaluation sensor. White light illumination is used. Alternatively, sequential illumination with different color illumination sources is used to capture images that are digitally processed to spectrally determine treatment levels of tissue components. For example, illumination from 660 nm red and 555 nm green LEDs with different melanin and blood absorption is used for capture. This helps to distinguish between the therapeutic photoresponse of pigmented lesions and the therapeutic photoresponse of blood vessels. Polarizer 867 may not be required for these measurements, and illumination source 862 may be unpolarized.

  FIG. 9 illustrates an embodiment of the present invention that uses multiple dose evaluation sensors 960 and 961 to provide more information available from a single sensor. For example, one dose evaluation sensor 961 can measure the dose before treatment, and the second dose evaluation sensor 960 can measure the treatment response after treatment. In this embodiment, the two dose evaluation sensors 960 and 961 are operatively connected to a controller 915 that controls treatment parameters of the electromagnetic source 910. Electromagnetic source 910 generates electromagnetic energy 930 that is delivered to the treatment site on skin 950 via contact plate 939 as the handpiece moves in direction 901.

  By using a dose evaluation sensor 961 before treatment and using another dose evaluation sensor 960 after treatment, the controller 915 can calculate the amount of treatment applied for a particular treatment setting condition. It becomes. The controller 915 can then make adjustments as needed to adjust the parameters of the electromagnetic source 910. This dose feedback loop allows real-time adjustment of treatment parameters.

  An example of a dose feedback loop uses a first capacitive dose evaluation sensor 961 and a second capacitive dose evaluation sensor 960. Each capacitive dose evaluation sensor measures the percentage of skin treated with non-ablative fractional resurfacing therapy. The first and second capacitive dose evaluation sensors 961, 960 measure the percentage of skin that the first capacitive dose evaluation sensor 961 has been treated before passing the current through the handpiece, and the second A capacitive dose evaluation sensor 960 is placed before and after the treatment window so as to measure the percentage of skin that has been treated after passing the handpiece current over the treatment site. The difference between the measured values of the two sensors 960, 961 describes the percentage of skin treated during the current passing of the handpiece over the treatment area. Calculation of the percentage of skin treated during current passage is used to prevent overtreatment applied by bulk heating of the tissue, for example, by reducing the laser treatment energy when an abnormally high percentage is calculated. The Other examples of suitable dose feedback sensors 960, 961 are described in US application Ser. No. 10 / 868,134, incorporated herein by reference.

  FIGS. 10 and 11 illustrate another embodiment of a dose evaluation sensor 1060/1160 that is operatively connected to a controller (not shown) that changes a treatment parameter in response to a measured amount from the dose evaluation sensor. ing. In a preferred embodiment, the dose evaluation sensor 1060/1160 is placed inside the handpiece 1000/1100. In an alternative embodiment, the dose evaluation sensor 1060/1160 is not placed inside the handpiece 1000/1100. In FIG. 10, the probe radiation source 1062 preferably generates a probe beam 1063 with a pulse width between 0.5 and 1000 ns, or between 5 and 100 ns, which is absorbed by the skin 1050 and is piezoelectric. A stress wave is generated that propagates through the interface between material 1065 and skin 1050. Probe beam 1063 may optionally pass through probe beam delivery lens 1064 to focus probe beam 1063 on or in skin 1050. The stress wave generates an electrical signal that is measured by an electrical signal detector 1060 that is electrically connected to the piezoelectric material 1065.

  The characteristics of the generated stress wave vary based on the mechanical and optical properties of the skin. The probe wavelength is selected such that there is a difference in absorption within the skin between untreated skin and treated skin. Alternatively, the pulsing conditions are selected so that the mechanical response is different for treated and untreated skin. Thus, the created stress wave is measured to determine whether it is approaching, reaching, or exceeding the desired therapeutic level of the probed skin. Examples of skin mechanical properties that can be examined using stress waves include skin elasticity, tension, and mechanical damping.

  The signature of the generated stress wave can be measured using a number of different techniques. One technique is shown in FIG. 10 and described above. In this technique, a transparent contact plate 1065 made from a piezoelectric material such as lithium niobate generates an electrical signal in response to mechanical stress waves. This electrical signal is measured by an electrical signal detector 1060. Suitable electrical signal detectors 1060 have been widely described in the art. The probe radiation source 1062 may be a Q-switched laser or a mode-locked laser. The laser may be a diode laser, a solid-state laser, an Nd: YAG laser, a gas laser, or the like.

  A second technique for measuring stress waves is to observe changes in the reflection pattern from a beam incident on the surface of the skin, as shown in FIG. In this configuration, the probe radiation source 1162 generates a probe beam 1163 that is absorbed by the skin 1150 to create a stress wave that propagates along the surface of the skin 1150, preferably between 0.5 and 1000 ns, or 5 To 100 ns pulse width. The probe beam 1163 may be optionally connected to any probe beam delivery lens 1164 and for optical or mechanical purposes such as focusing of the probe beam 1163 or mechanical enhancement of stress wave propagation. Pass through any contact plate 1165. A coherent illumination source 1172 generates a coherent illumination beam 1173 that is focused or collimated onto the surface of the skin using an optional coherent illumination lens 1174. The coherent illumination beam 1173 is diffracted from the surface of the skin by the stress wave created on the surface of the skin 1150 to generate a diffracted beam 1167. Diffracted beam 1167 is imaged to imaging detector 1160, such as a CCD camera, using imaging lens 1166.

  Components 1162, 1163 and 1164 are similar to similar components 1062, 1063 and 1064 in FIG. 10, and can be made from the same components as described above.

  Optional contact window 1165 is preferably composed of a transparent material such as fused silica or sapphire, through which probe beam 1163 passes.

  Probe beam 1163 is absorbed by skin 1150 and generates stress waves in skin 1150. As described above with respect to FIG. 10, the stress wave characteristics are dependent on the optical and mechanical parameters of the skin. Certain features, such as stress wave period and attenuation, can be evaluated by measuring a diffraction pattern from a diffracted beam 1167 imaged on the surface of imaging detector 1160.

  The coherent illumination source 1172 should be a coherent source, such as a HeNe laser. The angle of the coherent illumination beam 1173 with respect to the surface of the skin 1150 and the angle of the imaging system relative to the surface of the skin and relative to the coherent illumination beam 1173 are preferably aligned to maximize the measurement signal. Once the signal is measured, the stress wave damping constant and resonant frequency can be measured using the apparatus described by FIGS. DC filtering is also used to increase the signal to noise ratio of the detected signal.

  According to the technique described in FIGS. 10 and 11, preferably only the first reflected wave is measured and the subsequent signal from the scatter is temporarily filtered. This reduces confusion from multiple reflected waves. This is similar to an optical coherence tomography system where only the first reflected signal is used. Depending on the device's unique geometric properties, the device is used to measure most or local optical and mechanical properties of the skin that are altered by treatment.

  The examples described herein all illustrate the use of these techniques on human skin. The present invention is also applicable to the treatment of other tissues in the body. For example, puncture of the toenail surface for the treatment of nail fungus, soft palate for the treatment of diseases such as sleep apnea and hemorrhoids, local delivery of pharmaceuticals or nutritional supplements, or laser-based Treatment of heart tissue for TMR therapy all benefits from the use of the present invention.

  Although the detailed description includes numerous details, these details should not be construed as limiting the scope of the invention, but merely as exemplifying various examples and embodiments of the invention. It should be understood that the scope of the invention includes other embodiments not described in detail above. For example, in many of the above examples, a laser is used as an embodiment, but the laser can be generalized to RF, flash lamp, or other electromagnetic energy-based therapies. Various other modifications, changes and variations apparent to those skilled in the art will be apparent to those skilled in the art from the present invention disclosed herein without departing from the spirit and scope of the invention as set forth in the claims. Possible in the configuration, operation and details of the device.

  In the specification and in the claims, reference to an element in the singular is not intended to mean "one and only", but rather to mean "one or more" unless specifically stated otherwise. ing. Moreover, it is not necessary for an apparatus or method to address every issue that can be solved by various embodiments of the invention, as encompassed by the claims.

FIG. 2 is a schematic diagram of an embodiment of the present invention incorporating a position sensor and a dose evaluation sensor. 1 is a schematic diagram of an embodiment of the invention incorporating a light source, a star scanner wheel, and an optical position sensor. 1 is a schematic diagram of an embodiment of the present invention incorporating a light source, a star scanner wheel, and an optical position sensor. FIG. FIG. 2 is a schematic diagram of an embodiment of the invention incorporating a light source, a star scanner wheel, and an optical position sensor, illustrating one possible treatment pattern created by this embodiment. FIG. 2 is an illustration of a pattern that can be applied to a treatment site or a site adjacent to a treatment site to improve the measurement of the optical position sensor shown in FIG. FIG. 2 is an illustration of a pattern that can be applied to a treatment site or a site adjacent to a treatment site to improve the measurement of the optical position sensor shown in FIG. FIG. 2 is an illustration of a pattern that can be applied to a treatment site or a site adjacent to a treatment site to improve the measurement of the optical position sensor shown in FIG. FIG. 2 is a schematic view of an embodiment of the present invention in which one or more accelerometers are attached to the handpiece to measure the handpiece's positional parameters in three dimensions and / or three angular directions. FIG. 6 is a schematic diagram of an embodiment of the invention in which a transmitter and receiver are used to triangulate the position of a handpiece to measure position parameters in three dimensions and / or three angular directions. FIG. 2 is a schematic diagram of an embodiment of the invention in which at least one ultrasonic transmitter and at least one ultrasonic wave are mechanically coupled to the handpiece and utilize ultrasonic time-of-flight measurements. FIG. 2 is a schematic diagram of an embodiment of the present invention in which at least one ultrasonic transmitter and at least one ultrasonic receiver are mechanically coupled to the handpiece and utilize ultrasonic reflection measurements. FIG. 4 is an illustration of an embodiment of the present invention in which polarization imaging is used to measure changes in skin birefringence. FIG. 4 is a schematic diagram illustrating the use of a prior dose evaluation sensor and a subsequent dose evaluation sensor according to the present invention for measuring different skin responses to specific treatment parameters. FIG. 2 is an explanatory diagram of an embodiment of the present invention for measuring a skin response to a specific treatment parameter by measuring a shock wave trace created by an energy pulse incident on the skin, and an apparatus for measuring the shock wave trace using a piezoelectric material It is shown. FIG. 4 is an illustration of an embodiment of the present invention that measures skin response to a specific treatment parameter by measuring a shock wave signature created by energy pulses incident on the skin, and measuring the shock wave trace using a reflected probe beam The device is shown. FIG. 3 is a schematic diagram of an embodiment of the present invention in which one or more coil sensors are used to measure handpiece position parameters. It is explanatory drawing of the measured quantity produced by the system by FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 100 Handpiece 110 Electromagnetic source 115 Controller 120 Scan delivery unit 125 Scanner control part 130 Electromagnetic energy 139 Contact plate 150 Skin 160 Dose evaluation sensor 180 Position sensor

Claims (49)

A device for controlled fractional tissue treatment,
An electromagnetic source that generates electromagnetic energy;
A manually movable handpiece that delivers the electromagnetic energy to a target site on the human skin;
A dose evaluation sensor for measuring a skin response to a fractional treatment applied by the electromagnetic energy to the target site of human skin;
Operatively connected to the dose evaluation sensor, adjusting at least one operating parameter of the device in real time according to the measured amount of the dose evaluation sensor, and controlling the fractional therapy applied by the electromagnetic energy A controller to
A device comprising:   The apparatus of claim 16, wherein the dose evaluation sensor measures changes in skin birefringence resulting from the fractional treatment.   17. The device of claim 16, wherein the controller adjusts the spacing or density of treatment zones if excessive or insufficient treatment is detected by the dose evaluation sensor. The dose evaluation sensor is
An ultrasonic signal generator for generating ultrasonic shock waves;
The apparatus according to claim 16, further comprising: an ultrasonic detector that measures a characteristic parameter of the ultrasonic shock wave to quantify the change in the skin reaction.   17. The apparatus of claim 16, wherein the dose evaluation sensor measures changes in skin tone or distance between two features in or on the skin.   The apparatus of claim 16, wherein the dose evaluation sensor uses a coherent detection method.   The apparatus of claim 16, wherein the dose evaluation sensor captures an image of the treatment site when illuminated at different wavelength ranges, and the image is quantitatively compared by the sensor or the controller.   The dose evaluation sensor generates two data corresponding to skin conditions prior to the fractional treatment or part of the fractional treatment and skin conditions after the fractional treatment or part of the fractional treatment. The apparatus of claim 16 comprising a sensor.   The apparatus according to claim 16, wherein a treatment zone density is adjusted according to a measured amount of the dose evaluation sensor.   The dose evaluation sensor is configured to measure a response to at least one pre-treatment pulse to assess an appropriate treatment level for at least one subsequent pulse. Equipment.   The apparatus of claim 16, wherein the dose evaluation sensor captures two or more images formed by different illumination wavelengths.   The apparatus of claim 16, wherein the dose evaluation sensor captures two or more images formed by different polarizations.   The apparatus according to claim 12, wherein the dose evaluation sensor detects skin birefringence. A method of controlled fractional tissue treatment comprising:
Directing electromagnetic energy to a target site on a person's skin by a handpiece;
Manually moving the handpiece across the target site;
Detecting a skin response to a fractional treatment applied by the electromagnetic energy to the target site of human skin;
Controlling the fractional therapy delivered by the electromagnetic energy by automatically adjusting in real time at least one operating parameter of the electromagnetic energy in response to the sensed skin reaction. A device for controlled fractional tissue treatment,
Source means for generating electromagnetic energy;
Manually movable handpiece means for delivering said electromagnetic energy to a target site on human skin;
Sensor means for measuring a skin response to a fractional treatment applied by the electromagnetic energy to the target site of human skin;
Control operatively connected to the sensor means and controlling the fractional therapy applied by the electromagnetic energy by adjusting in real time at least one operating parameter of the device according to a measured quantity of the sensor means Means. A device for controlled fractional tissue treatment,
An electromagnetic source that generates electromagnetic energy;
A manually movable handpiece that delivers the electromagnetic energy to a target site on the human skin;
A position sensor for measuring at least one positional parameter of the handpiece;
Operably connected to the position sensor, and adjusting at least one operating parameter of the device in real time in response to the at least one position parameter measured by the position sensor, thereby allowing the electromagnetic energy to A controller for controlling to perform fractional treatment on the target site of the skin. Further comprising a dose evaluation sensor for measuring a skin response to the fractional treatment applied by the electromagnetic energy to the target site of human skin;
17. The controller of claim 16, wherein the controller further adjusts in real time at least one operating parameter of the device in response to a measured amount of the dose evaluation sensor to control the fractional therapy delivered by the electromagnetic energy. apparatus.   The apparatus of claim 17, wherein the position sensor is a non-mechanical position sensor.   The controller is not configured to maintain a handpiece speed exceeding a preselected range of speeds and / or a scanning speed substantially proportional to the speed, so that the laser pulse rate of the electromagnetic source is a handpiece speed and / or 19. The device of claim 18, wherein the device is adjusted proportionally to speed.   The apparatus of claim 17, wherein the position sensor comprises a magnetic position sensor.   The dose evaluation sensor generates two data corresponding to skin conditions prior to the fractional treatment or part of the fractional treatment and skin conditions after the fractional treatment or part of the fractional treatment. The apparatus of claim 17 comprising a sensor.   The apparatus according to claim 17, wherein a treatment zone density is adjusted according to a measured amount of the dose evaluation sensor.   18. The dose evaluation sensor is configured to measure a response to at least one pre-treatment pulse to evaluate an appropriate treatment level for at least one subsequent pulse. Equipment.   The apparatus of claim 16, wherein the position sensor is a non-mechanical position sensor.   The controller influences the fractional treatment by forming at least one of a new treatment rate, a new treatment density, and a new treatment pattern, depending on the amount measured by the non-mechanical position sensor. 25. The apparatus of claim 24, wherein at least one operating parameter of the electromagnetic source is adjusted in real time.   The apparatus of claim 16, wherein the electromagnetic source is a light source that generates a light beam, and the apparatus further comprises an optical scanner that directs the light beam to multiple locations of the target site.   27. The apparatus of claim 26, wherein the controller maintains a handpiece speed that exceeds a preselected range of speeds and / or a scanning speed that is substantially proportional to the speed.   27. The apparatus of claim 26, wherein the controller adjusts a laser pulse rate in proportion to a variable handpiece speed and / or speed.   27. The apparatus of claim 26, wherein the scanner blurs the light beam along the treatment zone by a predetermined amount by adjusting a scanning rate of the optical scanner or a pulse interval of the light source.   The apparatus according to claim 16, wherein the position sensor comprises a plurality of position sensors configured to measure a position parameter spanning a two-dimensional space and / or a three-dimensional space.   The apparatus of claim 16, wherein the position sensor comprises at least one of an accelerometer and a gyroscope.   The apparatus of claim 16, wherein the position sensor comprises a magnetic position sensor.   The apparatus of claim 32, wherein the magnetic position sensor comprises at least two loop antennas.   The position sensor includes at least two transmitter / receiver pairs, so that wireless communication is performed between the transmitter and the receiver, and a position parameter is a time-of-flight measurement amount and phase of the wireless communication signal The apparatus of claim 16, wherein the apparatus is calculated from at least one of the measured quantities.   The apparatus of claim 16, wherein the position sensor comprises an ultrasonic transmitter and an ultrasonic receiver.   The apparatus of claim 16, further comprising a plurality of light sources that illuminate the skin, wherein the controller distinguishes between two images illuminated by separate light sources. A method of controlled fractional tissue treatment comprising:
Directing electromagnetic energy to a target site on a person's skin by a handpiece;
Manually moving the handpiece across the target site;
Sensing at least one positional parameter of the handpiece;
Controlling the fractional therapy delivered by the electromagnetic energy by automatically adjusting in real time at least one operating parameter of the electromagnetic energy in response to the at least one positional parameter. .   38. The method of claim 37, wherein detecting the position parameter comprises optically detecting the position parameter using an optical position sensor mechanically coupled to the handpiece.   39. The method of optically sensing the positional parameter further comprises applying a contrast enhancing agent in or on the skin, the contrast enhancing agent increasing the signal to noise ratio of the optical position sensor. The method described.   40. The method of claim 38, wherein the optical contrast of the optical position sensor is enhanced by generating a treatment zone.   41. The method of claim 40, wherein generating a treatment zone comprises removing tissue.   40. The method of claim 38, wherein the light contrast of the light position sensor is enhanced by applying a light contrast enhancing agent to a person's skin.   43. The method of claim 42, wherein the total light absorption of the light contrast enhancing agent that falls within the 300-400 nm wavelength range is greater than the total light absorption that falls within the 400-700 nm wavelength range.   43. The method of claim 42, wherein the total light absorption of the light contrast enhancing agent falling within a wavelength range of 750-1000 nm is greater than a total light absorption falling within a wavelength range of 400-700 nm.   43. Illuminating the contrast enhancing agent at a wavelength that falls in the range of 300-1000 nm; and detecting a fluorescent signal from the contrast enhancing agent that falls substantially in the wavelength range of 350-1050 nm. The method described in 1.   43. The method of claim 42, wherein applying the light contrast agent comprises spreading and / or applying the light contrast agent using one or more rollers, stamps, and stencils.   43. The method of claim 42, wherein the light contrast enhancing agent is applied in a pattern with non-uniform spacing between adjacent graphics.   43. The method of claim 42, wherein applying the light contrast agent comprises attaching an adhesive to the skin in which the light contrast enhancing agent is embedded. A device for controlled fractional tissue treatment,
Source means for generating electromagnetic energy;
Manually movable handpiece means for delivering said electromagnetic energy to a target site on human skin;
First position sensor means for measuring at least one position parameter of said handpiece means;
Second sensor means for measuring a skin response to the fractional treatment applied by the electromagnetic energy at the target site of human skin;
Operatively connected to the first sensor means and the second sensor means, wherein at least one operating parameter of the device is determined in accordance with a measured quantity from the first sensor means and the second sensor means. And a control means for controlling to perform fractional treatment on the target site of the human skin by the electromagnetic energy by adjusting in real time.

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